Evidence map›Paper›PMID 41174638›Full record

ArticleTrials2025

Real world implementation of AlcoChange, a smartphone digital therapeutic to improve outcomes from alcohol-related liver disease: protocol for an individually randomised parallel group controlled trial.

Andrew Cook, Jonathan Bamber, Fay Chinnery, Fran Webley, Elizabeth Dixon, Lorraine McDonagh, Richard Allen, Ravan Boddu, Haqeeqat Gurm, Francesca Saffioti and 10 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Andrew CookSouthampton Clinical Trials Unit, University of Southampton, Southampton,, UK.
Jonathan BamberInstitute for Liver and Digestive Health, University College London, London, UK.
Fay ChinnerySouthampton Clinical Trials Unit, University of Southampton, Southampton,, UK.
Fran WebleySouthampton Clinical Trials Unit, University of Southampton, Southampton,, UK.
Elizabeth DixonSouthampton Clinical Trials Unit, University of Southampton, Southampton,, UK.
Lorraine McDonaghInstitute of Epidemiology and Health Care, University College London, London, UK.
Richard AllenPatient and Public Involvement and Engagement (PPIE) representative, London, UK.
Ravan BodduCyberliver Ltd, London, UK.
Haqeeqat GurmInstitute for Liver and Digestive Health, University College London, London, UK.
Francesca SaffiotiDepartment of Gastroenterology, John Radcliffe Hospital , Oxford, UK.
Neil RajoriyaThe Liver Unit, University Hospital Birmingham NHS Foundation Trust , Birmingham, UK.
Linda SobellNova Southeastern University, Fort Lauderdale, USA.
Mark SobellNova Southeastern University, Fort Lauderdale, USA.
Beth StuartSouthampton Clinical Trials Unit, University of Southampton, Southampton,, UK.
Ravi KumarCyberliver Ltd, London, UK.
Zia SadiqueDepartment of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.
Megan LawrenceSouthampton Clinical Trials Unit, University of Southampton, Southampton,, UK.
Sean EwingsSouthampton Clinical Trials Unit, University of Southampton, Southampton,, UK.
Rajiv JalanInstitute for Liver and Digestive Health, University College London, London, UK.
Gautam MehtaInstitute for Liver and Digestive Health, University College London, London, UK. gautam.mehta@ucl.ac.uk.ORCID http://orcid.org/0000-0002-5696-359X

Funding

Invention for Innovation 201002
6 · The paper itself

Abstract

backgroundDeaths from alcohol-related liver disease (ARLD) are rising in the UK, representing a significant public health crisis. Effective interventions are urgently needed to reduce alcohol consumption and improve outcomes for individuals with ARLD. While behaviour change interventions (BCIs) are effective, their scalability is limited. Digital therapeutics offer a promising avenue for delivering BCIs remotely and at scale. AlcoChange, a novel digital therapeutic combining a smartphone app and digital breathalyser, delivers personalised BCIs based on patient triggers. Preliminary data suggest its potential efficacy in reducing alcohol use.

methodsThis is a multi-centre, two-arm, parallel-group, individually randomised controlled trial comparing usual care (review by a hospital Alcohol Care Team and brief intervention) with usual care plus AlcoChange in patients with ARLD. POPULATION: Adults aged 18 years or older with a diagnosis of ARLD (including cirrhosis, fibrosis, steatohepatitis, or recent alcoholic hepatitis) who have been advised to abstain from alcohol and intend to do so, and who have access to a smartphone.

interventionUsual care plus AlcoChange, comprising a smartphone app and digital breathalyser delivering personalised behaviour change techniques. COMPARISON: Usual care alone. OUTCOME: The primary outcome is the proportion of patients abstinent or reporting low-risk alcohol consumption (< 14 units/week) at 180 days post-randomisation, assessed using the Timeline Follow-Back (TLFB) method. Secondary outcomes include self-reported alcohol use at various time points, liver disease severity, health-related quality of life, healthcare resource utilisation, and cost-effectiveness. Four hundred participants will be recruited from up to 18 NHS hospitals in England and randomised 1:1. A mixed-methods approach was used to develop the trial protocol, including a theory of change framework and bespoke training materials for the TLFB assessment. DISCUSSION: This trial will evaluate the real-world efficacy and cost-effectiveness of AlcoChange in reducing alcohol consumption and alcohol-related harm in individuals with ARLD. The study addresses the urgent need for scalable interventions to combat the rising burden of ARLD in the UK. The pragmatic design and mixed methods approach to implementation aim to enhance the generalizability and impact of the findings. The trial will provide valuable evidence to inform clinical practice and policy regarding the use of digital therapeutics for alcohol use disorder and liver disease.

Indexed as

Alcohol DrinkingBehavior TherapyLiver Diseases, AlcoholicMobile ApplicationsSmartphoneAlcohol AbstinenceCost-Benefit AnalysisHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicTelemedicineTime FactorsTreatment OutcomeUnited Kingdom

Identifiers

PMID41174638
PMCPMC12576983

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.